FDA.reportPublic FDA data

Low-pressurehose assembly, 2m, 02 green DISS/ OHMEDA

Primary DI
04054685271619
Brand
Low-pressurehose assembly, 2m, 02 green DISS/ OHMEDA
Company
WEINMANN Emergency Medical Technology GmbH + Co. KG
Model
36336
Published
2020-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193191000MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KG2020-11-20BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054685271619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054685271619040546852716194054685271619

GMDN Terms#

Term, Definition table
TermDefinition
General-gas low pressure tubing, reusableA non-sterile length of flexible tube intended to conduct compressed medical gas typically from a cylinder to a respiratory medical device outside of a static clinical environment (e.g., emergency CPAP device); it is not dedicated for use with a specific gas. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 15 bar), having been reduced by a regulator from a high pressure. The tubing is available in various lengths, including standard coil lengths; it is not colour-coded. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342832477
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054685129996Disposable breathing circuit, 1.70m281102020-12-07
04054685091286MEDUtrigger209002021-02-26
04054685268947MEDUMAT Easy CPR203152020-12-09
04054685091408MEDUtrigger209202020-12-07
04054685271589Low-pressurehose assembly, 2m, 02 green DISS/ DISS363352020-12-07
04054685271596Low-pressurehose assembly, 2m, 02 green DISS/ CHEMETRON363322020-12-07
04054685271602Low-pressurehose assembly, 2m, 02 green DISS/ PURITAN BENNET363342020-12-07

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Primary DI, Brand, Company table
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